The present invention is directed to an apparatus, kit and method for preventing infection associated with transcutaneous access during medical and surgical procedures. Typical antimicrobial medical and surgical preparation procedures, such as preparation for accessing blood vessels with catheters and other invasive instruments, attempt to reduce the incidence of infection by seeking to eliminate microbes at the skin's surface. However, studies have confirmed that over 20% of microbes reside under the skin's surface, such as in the pores and skin appendages (e.g. hair follicles, sweat glands, sebaceous glands, and the like), where topical preparations cannot adequately penetrate. Elegant research has shown that microbes are present on and in the skin and skin structures after even the most thorough preparation. Research has also shown that it is these microbes that are responsible for most of the catheter related bloodstream infections. The microbes are introduced during insertion of the catheters and while the catheters are left in place as a result of direct contact of the instruments and catheter with the skin. The present invention thus seeks to reduce the incidence of bloodstream infections arising from such access and thereby reduce morbidity, mortality, and healthcare costs.
In 2002, the Centers for Disease Control and Prevention published guidelines in its Morbidity and Mortality Weekly Report in which they outline steps to minimize blood stream infections. The guidelines indicate that in American intensive care units, the average infection rate for central venous catheters is 5.3 per 1000 catheter days. At 15 million catheter days per year, there are an estimated 80,000 preventable infections per year. The mortality rate with these infections ranges from 0% to 35%. Additional costs range from $34,508 to $56,000 per infection for an annual total of $296 million to $2.3 billion. When entire hospitals are considered, there are an estimated 250,000 catheter related bloodstream infections per year with mortality rates of 12% to 25% and a cost of $25,000 per infection.
U.S. Pat. No. 6,074,380 to Byrne et al., incorporated herein by reference, discloses one attempt to reduce the risks of such infections in transcutaneous surgery though the use of a shallow dish-shaped shield device with an instrument access port. However, the Byrne et al. shield device is a bulky, funnel-type apparatus that is not practical or easy to position and use. Further, the Byrne et al. device is relatively complex to manufacture.
Accordingly there is a need for an inexpensive, easy-to-manufacture and easy-to-position shield apparatus that resists infection during surgical access into the body of humans and animals, including vascular procedures, orthopedic procedures, organ access, neurosurgery, catheter/tubing insertion, arthroscopic procedures, cosmetic surgeries (e.g. liposuction) and the like.